Ratnakumaran Raguprakash, To Natalie, Gracie David J, Selinger Christian P, O'Connor Anthony, Clark Tanya, Carey Nicola, Leigh Katherine, Bourner Lynsey, Ford Alexander C, Hamlin P John
a Leeds Institute of Biomedical and Clinical Sciences , University of Leeds , Leeds , UK.
b Leeds Gastroenterology Institute , St. James' University Hospital , Leeds , UK.
Scand J Gastroenterol. 2018 Jun;53(6):700-707. doi: 10.1080/00365521.2018.1464203. Epub 2018 Apr 24.
Recently, the infliximab biosimilar (CT-P13) received market authorisation for inflammatory bowel disease (IBD), allowing cost benefits when switching to CT-P13. We aim to assess the efficacy and safety of switching from originator infliximab to CT-P13 for new and existing patients.
Treatment response, remission, primary and secondary loss of response rates, and adverse events in patients who initiated infliximab originator in the 12 months pre-switch (n = 53) were compared with the patients who initiated CT-P13 in the 12 months post-switch (n = 69). Sustained responses were compared for existing infliximab originator patients who switched to CT-P13 (n = 191) and those who continued with the originator (n = 19).
There was no difference in remission (58.1% vs. 47.4%, p = .37), response (12.6% vs. 10.5%, p = .80), secondary loss of response (24.6% vs. 42.1%, p = .10), or adverse events (4.7% vs. 0% p = 1.0) between those who switched to CT-P13 and those who continued infliximab originator. There was no difference in remission (42.0% vs. 26.4%, p = .074), response (21.7% vs. 22.6%, p = .91), primary non-response (5.8% vs. 15.1%, p = .09), secondary loss of response (21.7% vs. 22.6%, p = .91), or adverse events (8.7% vs. 11.3%, p = .63) in those who initiated CT-P13 compared with infliximab originator.
There was no difference in the efficacy and safety of infliximab originator and CT-P13 during the first 12 months after switching.
最近，英夫利昔单抗生物类似药（CT-P13）获得了用于治疗炎症性肠病（IBD）的市场授权，改用CT-P13可带来成本效益。我们旨在评估新患者和现有患者从原研英夫利昔单抗转换为CT-P13的疗效和安全性。
将转换前12个月开始使用原研英夫利昔单抗的患者（n = 53）与转换后12个月开始使用CT-P13的患者（n = 69）的治疗反应、缓解情况、原发和继发反应丧失率以及不良事件进行比较。对转换为CT-P13的现有原研英夫利昔单抗患者（n = 191）和继续使用原研药的患者（n = 19）的持续反应进行比较。
转换为CT-P13的患者与继续使用原研英夫利昔单抗的患者在缓解情况（58.1%对47.4%，p = 0.37）、反应情况（12.6%对10.5%，p = 0.80）、继发反应丧失（24.6%对42.1%，p = 0.10）或不良事件（4.7%对0%，p = 1.0）方面没有差异。与原研英夫利昔单抗相比，开始使用CT-P13的患者在缓解情况（42.0%对26.4%，p = 0.074）、反应情况（21.7%对22.6%，p = 0.91）、原发无反应（5.8%对15.1%，p = 0.09）、继发反应丧失（21.7%对22.6%，p = 0.91）或不良事件（8.7%对11.3%，p = 0.63）方面没有差异。
转换后的前12个月内，原研英夫利昔单抗和CT-P13在疗效和安全性方面没有差异。
